Clinical research associate jobs in Hempstead, NY - 523 jobs

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This field-based position is based in either New York or New Jersey. **Purpose and Scope:** A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL,) Clinical Trial Manager (CTM,) Clinical Trial Specialist (CTS,) and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial related activities for assigned protocols. Responsibilities may include assisting with or primary responsibility for: + Site Selection + Pre-trial assessment + Site level Study Participant recruitment/retention plans + Site Activation/Initiation + On-site and remote monitoring + Overall site relationship management in collaboration with other sponsor roles that interact with the site + Close-out activities Reports to the regional Site Management Lead Early or Late-Stage Site Monitoring & Management Organization. This position may provide mentoring to less experienced site managers and may provide oversight for contract team members. A matrix relationship to the study teams is essential in effective execution of this role. **Responsibilities & Accountabilities:** + Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials. + Develops meaningful site relationships through consistent collaborative communication and engagement. + May participate in site feasibility and/or pre-trial site assessment visits. + Attends/participates in investigator meetings as needed. + May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study. This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study. + Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits. + Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe. + Ensure site compliance with study protocol, ICH-GCP, and local/country regulations. + Ensure ongoing adequacy of site (facilities, staff) for trial conduct. + Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA + Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas. + Ensures site non-IMP study supplies are adequate for trial conduct. + Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed. + Oversees the appropriate destruction of clinical supplies. + Ensures site staff complete data entry and resolve queries within expected timelines. + Ensures validity and completeness of data collected at trial sites. + Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate. + Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management. + Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders. + Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times. + Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities. + Works closely with CTL to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits. + Prepares trial sites for close out, conduct final close out visit. + Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff. + May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate. + May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines. **Qualifications:** **Required** + BA/BS degree with ≥5years of experience in pharmaceutical related drug development or direct equivalent experience. + Five years site monitoring and/or site management experience. + A minimum of 2 years of early phase Oncology therapeutic area experience. + Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines. + Strong critical thinking and problem-solving skills. + Strong IT skills in appropriate software and company systems. + Willingness to travel up to 40% with overnight stay away from home. + Proficient in speaking and writing English. + Good written and oral communication. **Preferred Qualifications:** + Experience working cross-functionally and in matrix teams + Experience in executing Lead CSM role + Experience mentoring more junior site monitors or site managers + Experience working in early development studies **Salary Range** $122,500 - $192,500 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Early Development Clinical Operations Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Regional Cancer Care Associates (RCCA) is looking for an exceptional Clinical Research Manager to join the team. This position manages clinical research program and operations in accordance with USON SOP and ICH GCP guidelines. Coaches and develops staff. Develops research accountability standards, metrics, and reports and identifies areas for improvement Implements action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. ICH GCP guidelines. Coaches and develops staff. Develops research accountability standards, metrics, and reports and identifies areas for improvement Implements action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. Ensures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures(SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. Supports and adheres to the US Oncology Compliance Program, to include Code of Ethics and Business Standards. This individual must also possess strong multi-tasking abilities and bring positivity and passion to their work. If you want to join a team that is on the cutting edge of cancer care, while always putting the patient first, we want to hear from you! Employment Type: Full Time Location: Belleville, NJ As of the date of this posting, RCCA offers a comprehensive benefits package for this position, subject to eligibility requirements. In addition to the salary, we provide: Health, dental, and vision plans, Wellness program, Health savings account - Flexible spending accounts, 401(k) retirement plan, Life insurance, Short-term disability insurance, Long-term disability insurance, Employee Assistance Program (EAP), Paid Time Off (PTO) and holiday pay, Tuition discounts with numerous universities. We believe these benefits underscore our commitment to the well-being and professional growth of our employees. Key Responsibilities: Manages clinical research program and operations in accordance with USOR SOP and ICH GCP guidelines. Responsible for ensuring at the administrative level that all research activities are coordinated with affected departments within the practice. Coaches and develops staff. Responsible for recruitment, interviewing, recommending hires, assessing performance, recommending salary changes, and progressive discipline. Enforces adherence to company policies. Develops research accountability standards, metrics, and reports and identifies areas for improvement. Implement action plans designed to improve practice research operations and quality assurance functions. Collaborates with practice management staff in the development and implementation of research budget that includes accrual targets and financial objectives. Develops accountability standard to ensure that targets and budgets are achieved. Collaborates with the SRL, physicians of the practice, research committee, and other research management in the process of study selection for the research program. Responsible to promote or market research program to the practice, community and referring physicians. Responsible for coordinating research activities with other (non-USOR) bases or sponsors. Requirements Minimum Job Qualifications (Knowledge, Skills, & Abilities): Education/Training: Bachelors degree in a clinical or scientific related discipline desired, Bachelors degree in nursing preferred. Business Experience: Minimum of 7 years clinical nursing experience or scientific related discipline required, preferably in oncology Minimum of 2 years of supervisory experience preferred, experience in clinical research preferred If required for state of practice, current licensure as a registered nurse (RN) SoCRA or ARCP certification preferred Specialized Knowledge/Skills: Excellent communication skills, strong ability to multitask Strong interpersonal skills Must be able to work in a fast paced constantly changing environment Knowledge and proficiency in all basic computer programs, windows, excel etc. Special knowledge of GCP and ICH guidelines Specific knowledge of all aspects of clinical research - ability to read, analyze and interpret technical items such as protocols, informed consent documents, and regulatory documents, ability to solve problems and implement solutions Knowledge of medical terminology, nursing assessment, clinical medicine, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology as it relates to clinical trails Basic knowledge of financial management to include budgeting and contracting, understanding of site financials including revenue cycle Working Conditions: Traditional office environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements (Lifting, standing, etc.) - Large percent of time performing computer based work is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)

Cellectis' Clinical Sciences (CS) organization is seeking a highly motivated and experienced clinical Research Scientist to support the both the development and execution of our innovative proprietary UCART allogeneic CART cell therapies programs. The Director, Clinical Research Scientist participates in design and implementation of the development strategy and supports the Clinical Science Physicians with various deliverables necessary for effective and efficient planning and execution of their assigned program. Additionally, the successful candidate in this role would also be responsible for working closely with the Clinical Operations Team to support the development of clinical development processes, templates and potentially training and management of junior clinical research scientists. Job Responsibilities Supports the clinical development of assigned programs and participates and supports the design and implementation of the development strategy Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA) The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience May co-lead study team meetings in partnership with Clinical Operations study lead Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums, act as primary point-of-contact for clinical study or program for clinical science related activities, and providing clinical science inputs into study safety reporting. Clinical Scientists are likely to have regular external interactions with a variety of internal and external partners and stakeholders, such as cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups. They may also, alongside the Clinical Sciences Physician, participate in external interactions with health authorities (HAs) Provides strategic clinical science support for assigned studies and programs Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required May author and/or review clinical narratives in conjunction with pharmacovigilance in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming Develops and/or provides input for clinical presentation slides and other materials for internal/external meetings (e.g., DSMB, EOC, site and CRA training for SIV and investigator meetings) and/or ongoing communications for review/discussion in concert with Clinical Science Physicians In concert with Clinical Sciences Physicians provide clinical contributions to internal documents and presentations including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts) As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists Where applicable, may manage one or more direct reports and is, in such instances responsible for hiring, training, developing, and retaining talent on his/her staff. As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment Core Competencies Strong interpersonal, verbal communication and influencing skills: can influence without authority and is willing to cultivate relationships with key partners and stakeholders, both internally and externally Outstanding written communication skills Strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points Comfortable working in fast paced entrepreneurial environment Ability to travel up to 20% Education and Experience Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred) Minimum of 5 years pharma/biotech industry experience in clinical development in oncology/hematology clinical trials experience in CAR T-cell therapy is preferred Experience in data review, data cleaning, managing and interpreting clinical trials results as well as exposure to writing protocols Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research Physical Requirements In office 4 days per week, required Sedentary, desk position Salary Range $175,000-225,000 (final salary is dependent on candidate's experience and credentials)

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications 3-5 years Strong Project Management Regulatory submission experience Oncology experience Participate on a cross functional team focused on US regulatory submissions (FDA). * Previous Pfizer experience is preferred; Pharmaceutical/biotech experience mandatory. Familiarity with U.S. NDA processes required Provides Financial Oversight Forecasts and manages high level clinical trial budget. Oversees the study risk planning process (e.g. IQMP) Works proactively with AP/CRO Supports Practical Clinical Trial Design o Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design. o Initiates and ensures a Protocol Operational Feasibility and Budget assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed. o Facilitates early engagement of Alliance Partners/Vendors when needed. Additional Information $70/hr 6 months

Collabera is ranked amongst the top 10 Information Technology (IT) staffing firms in the U.S., with more than $525 million in sales revenue and a global presence that represents approximately 12,000+ professionals across North America (U.S., Canada), Asia Pacific (India, Philippines, Singapore, Malaysia), and Europe (Ireland, Netherlands, Poland, United Kingdom). We support our clients with a strong recruitment model and a sincere commitment to their success, which is why more than 75% of our clients rank us amongst their top three staffing suppliers. Not only are we committed to meeting and exceeding our customer's needs, but also are committed to our employees' satisfaction as well. We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera. As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as the “Best Staffing Firm to Work For” for five consecutive years since 2012. Collabera has over 50 offices across the globe with a presence in ten countries and provides staff augmentation, managed services and direct placement services to global 2000 corporations. For consultants and employees, Collabera offers an enriching experience that promotes career growth and lifelong learning. Visit ***************** to learn more about our latest job openings. Awards and Recognitions --Staffing Industry Analysts: Best Staffing Firm to Work For (2016, 2015, 2014, 2013, 2012) --Staffing Industry Analysts: Largest U.S. Staffing Firms (2016, 2015, 2014, 2013) --Staffing Industry Analysts: Largest Minority Owned IT Staffing Firm in the US. Job Details: Job Title: Clinical Research Specialist Location: Manhattan, NYC Duration: 6 months (could go beyond) Job Description: · Job function includes, study coordination and implementation of a new clinical study. · The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies. · The position works closely with the Principal Investigator, members of the department, study sponsors and monitors, and the institution, to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of clinical studies. It is a full time position, Monday-Friday. Positive candidate must possess the following: · Experience as a study coordinator 1-2 years in a hospital or outpatient setting, preferably with imaging trials, and EDC systems. · High organizational ability with strong attention to detail · Flexibility with a team player attitude · Professionalism · Proficient with MS Office, Outlook and Internet Explorer · Critical thinker and problem solver · Please include a cover letter with your resume. Qualifications Education Requirements : 4 yr Bachelor's Degree. Clinical research experience required. Additional Information To know more about this opportunity, please contact: Ujjwal Mane ************ ****************************

Noom is on a mission to help people live better, longer. We're a consumer-led digital health company, connecting people to content, coaching, community, and clinicians, to build lasting habits and live healthier lives. We're a high-growth organization powered by science, technology, and world-class talent. When you join Noom, on any team, you'll see the impact of your work on the world. Our Clinical Research Team Noom's Clinical Research team is at the heart of our evidence-based approach to whole-person health. We design and conduct rigorous studies to evaluate the effectiveness of our programs and interventions, shaping the future of digital health through science. By aligning clinical integrity with strategic goals, our team ensures Noom's offerings are both credible and transformative. About the Role As Noom continues to expand its research efforts, we are seeking a Clinical Research Operations Manager to support the execution of high-quality research across clinical and UX research initiatives. This role partners closely with the Head of Clinical Research to coordinate study operations, manage regulatory processes, and ensure research initiatives are delivered efficiently and compliantly. You will play a key role in enabling study success through strong project management, operational rigor, and cross-functional collaboration. You Will Own operational execution across clinical and UX research studies, including timelines, milestones, and deliverables Triage incoming Jira Research Ask Tickets and maintain the Research Prioritization deck Perform budget reconciliation and planning across clinical research programs Track timelines and deliverables, surfacing and escalating blockers as needed Develop operational processes for new studies, including SOPs and training documentation Full command of study start-up with milestone planning and ongoing troubleshooting Oversee logistics for participant recruitment, tracking, and data management workflows Train and oversee Study Coordinators, ensuring high quality data capture and execution of protocols with minimal protocol deviations Manage Institutional Review Board (IRB) submissions, renewals, and amendments Ensure all research activities align with ethical guidelines, regulatory standards, and Noom policies Organize the team and processes that translate claims needs into scoped research projects Develop study protocols and measurement tools Manage and maintain records for study preregistration Collaborate with statisticians and analysts to interpret data and generate insights Manage and contribute to scientific outputs including manuscripts, white papers, and presentations Support integration of research findings into product and business strategies About You If you're interested in shaping the future of health by operationalizing high-impact clinical research, this role may be for you! You Have A Master's degree required; PhD preferred in a clinical research or health outcomes discipline (e.g., psychology, public health) 3+ years of experience supporting clinical research studies in an operational, coordination, or project management capacity At least 2 years of experience with IRB documentation and compliance Experience using Python and/or R for data analysis Familiarity with multiple electronic data capture systems (EDCs) CCRC or PMP certification preferred Required authorship on peer-reviewed publication(s); first-author manuscripts preferred Experience presenting research at academic conferences Strong project management capabilities, including timeline and resource tracking Ability to manage multiple priorities in a fast-paced, evolving environment Strategic thinking with the ability to align research with broader business objectives Excellent interpersonal and cross-functional collaboration skills What Makes This Job Amazing High-impact role bridging science and strategy at a mission-driven company Opportunities to publish and present original research Collaborative, cross-functional environment with world-class researchers and clinicians Autonomy and ownership over research operations and innovation Compensation Package The US base salary for this full-time position is $120,000. This reflects the salary target for the position for US-based candidates, at the time of posting. The actual salary offer is based on factors including relevant experience and training, assessment of functional skills and behavioral competencies, and location, among others. Other elements of Noom's Compensation Package Noom offers a comprehensive and generous total rewards package. This may include a discretionary performance-based bonus, stock awards, healthcare (featuring a plan with premiums covered by Noom), paid holidays and paid leave (including Summer Fridays), 401k program, and various cash stipends and budgets for employees (wellness, tech, learning & development, etc). Location This position is a hybrid role, with 2 days per week on-site required in one of our offices: New York, NY, USA Princeton, NJ, USA More About Noom Noom is a leading whole-person health platform on a mission to help people live better, longer. We combine personalized medication with the science of behavior change and psychology, to help people build lasting habits and live longer, healthier lives. With nationally-recognized, holistic programs spanning weight, diabetes prevention, GLP-1 support, menopause, longevity, and more, we serve millions through health plans, employers, and direct-to-consumer offerings. As a trailblazer in the world of health and wellness, Noom makes healthy living easy, fun, and deeply rewarding. Join us in shaping the future of health. Whether you're remote or in-office, you'll be part of a passionate, mission-driven team working to make the world a healthier place-one habit at a time. Noom is proud to be an Equal Opportunity Employer, and all applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, caste, national origin, physical or mental disability, protected veteran status, age, or any other characteristic protected by applicable law. Noom is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities. To help protect against potential hiring scams, please be aware that all email communications from the Noom Talent team and/or hiring managers will come only from ************ email address. Please ignore any messaging or communication from other domains (e.g. @noom.team). Noom will never ask you for personal payment, require you to purchase equipment, conduct an interview process or messaging exchange via Microsoft Teams, or extend a job offer without the completion of a multi-step interview process featuring a combination of phone, Zoom, and in-person interviews, as well as references. If you are unsure about the validity of a Noom job posting on another website, we strongly encourage you to apply directly through our website.

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

Clinical Research Site Manager The Site Manager's job is to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. Also To ensure study enrollment meets or exceeds Sponsors' expectations and company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Responsible for immediate supervision and performance of the assigned site staff under the supervision of the Site Director or Director of Site Operations. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. It is the responsibility of the Site Manager to make sure all the relevant training is completed prior to performing any applicable tasks on the assigned study. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate as well as timely follow-up on the action items, at their respective sites. Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocol(s) at their respective site(s). Ensuring clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs, and guidance documents. Ensuring data quality, subject retention, and compliance, timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Accomplishing site objectives by managing staff; facilitating staff training as applicable; communicating job expectations Coaching, counseling, and disciplining the employees as applicable. To develop, coordinate, and enforce site-specific systems, policies, procedures, and productivity standards. Communicating and effective implementation of strategic goals from senior management to the site team. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly, and quarterly assigned goals are met for their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. Any other matters as assigned by management. KNOWLEDGE & EXPERIENCE Education: Bachelor's degree preferred Advanced degree preferred Experience: At least 4 years of clinical research coordinator experience, including 2 years of management experience at a clinical research organization. Credentials: Certified Clinical Research Coordinator (CCRC) or equivalent certification preferred. Knowledge and Skills: Solid teamwork, organizational, interpersonal, and problem-solving skills and attention to detail. Critical Thinking Active Listening Reading Comprehension - Understanding written sentences and paragraphs in work-related documents. Speaking and Writing to communicate effectively as appropriate for the needs of the audience. Ability to multitask, adhere to deadlines, and work both independently and cooperatively with interdisciplinary teams. Strong computer skills in relevant software and related clinical systems are required. Comprehensive knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs.

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Position Overview: The Development Clinical Research Scientist (CRS) in the Breast Cancer Franchise will be primarily focused on late phase assets in an evolving portfolio. This role is pivotal in the design, execution, and analysis of clinical trials that support the development of innovative breast cancer therapies. The CRS ensures that all medical team activities align with the medical vision and stay in sync with current regulations, laws, guidance (e.g. FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, and Lilly policies. This position requires close collaboration with cross-functional partners including medical affairs, clinical operations, regulatory, statistics and data science to advance the oncology pipeline and improve patient outcomes. The successful candidate will proactively identify, assess, and mitigate risks related to medical oversight of clinical trials and contribute to regulatory submissions, external engagements, and data disclosure activities. This role includes supervisory responsibilities and requires demonstrated leadership in clinical development, strong mentoring capabilities, and exceptional written communication skills-particularly for external data disclosures and regulatory documentation. Primary Responsibilities * Contribute to the development and execution of clinical strategies for breast cancer programs. Maintain a focus on accelerating timelines while ensuring quality. * Demonstrate compliance with procedures and be accountable for compliance of team members. * Lead completion of clinical trial documents including protocols, amendments, investigator brochures, informed consent forms, and clinical study reports. * Lead and contribute in medical monitoring activities, including data review, safety assessments, and protocol deviation management. * Collaborate with Global Medical Leads, statisticians, and clinical operations to ensure scientific integrity and operational excellence. * Collaborate with Global Patient Safety on risk management planning. * Serve as a resource for sites, monitors, investigators, and ethics committees to address study-related questions. * Provide scientific input for site selection, investigator meetings, steering committees, and clinical trial training. * Partake in data analysis, scientific dissemination, and preparation of final study reports. * Analyze and contextualize clinical data to support decision-making and portfolio strategy. * Contribute to strategy and innovation through cross-functional working groups. * Support planning and execution of symposia, advisory boards, and other external engagements. * Develop and review scientific materials including slide decks, abstracts, posters, and manuscripts. * Support regulatory submissions (e.g., INDs, NDAs, BLAs) and prepare materials for health authority interactions. Scientific & Technical Expertise and Development * Stay current with medical literature and scientific developments in breast oncology. * Maintain deep knowledge of clinical practice trends, access considerations, and relevant preclinical and clinical data. * Provide scientific consultation to medical affairs, health outcomes, and commercial teams. * Assist in planning and execution of opportunities for external scientific engagement and attend relevant symposia. Leadership & Professional Development * Model leadership behaviors and lead matrixed, cross-functional teams. Direct supervision of a team of more junior scientists. * Set and help members of the team pursue developmental goals though coaching to drive exceptional team performance while elevating the individual. Basic qualifications: * PhD with 3+ years of industry experience) OR (BS Degree and experience in Health-related field with 10+ years' industry experience * 3+ years of clinical research scientist experience/clinical trial experience * Leadership experience Additional Information/Preferences: * Direct Line Leadership experience Breast cancer disease state knowledge/experience * An advanced health/medical/scientific graduate degree such as, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) * Experience with all phases of a trial lifecycle: design, study start up, implementation, and regulatory submission. * Strong communication, interpersonal, teamwork, organizational, and negotiation skills * Demonstrated ability to influence others (both cross-functionally and within the function) to build a positive working environment. * Ability to engage in domestic and international travel to the degree appropriate to support the business of the team. * Fluent in English, verbal and written communication Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $177,000 - $308,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

About Us We're Maimonides Health, Brooklyn's largest healthcare system, serving over 250,000 patients each year through the system's 3 hospitals, 1800 physicians and healthcare professionals, more than 80 community-based practices and outpatient centers. At Maimonides Health, our core values H.E.A.R.T drives everything we do. We uphold and maintain Honesty, Empathy, Accountability, Respect, and Teamwork to empower our talented team, engage our respective communities and adhere to Planetree's philosophy of patient-centered care. The system is anchored by Maimonides Medical Center, one of the nation's largest independent teaching hospitals and home to centers of excellence in numerous specialties; Maimonides Midwood Community Hospital (formerly New York Community Hospital), a 130-bed adult medical-surgical hospital; and Maimonides Children's Hospital, Brooklyn's only children's hospital and only pediatric trauma center. Maimonides' clincal progams rank among the best in the country for patient outcomes, including its Heart and Vascular Institute, Neuroscience Institute, Boneand Joint Center, and Cancer Center. Maimonides is an affiliate of Northwell Health and a major clinical training site for SUNY Downstate College of Medicine. Overview Maimonides is currently seeking a Clinical Trials Support Specialist. Responsibilities We currently have a unique full time opportunity for a Clinical Trials Support Specialist in our Cancer Center Administration Department. Qualifications We require: * Bachelor's of Science in Biology or Chemistry; Master's preferred. * 2 years of research experience in the medical field or an advanced degree in a Biology or Chemistry required. Pay Range USD $66,779.00 - USD $66,779.00 /Yr. Equal Employment Opportunity Employer Maimonides Medical Center (MMC) is an equal opportunity employer.

A Study Manager is responsible to ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. In addition, ensure study enrollment meets or exceed Sponsors' expectations and company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA certifications on a timely basis. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s). Adherence and compliance to the assigned protocols at their respective site(s). Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Ensuring visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) and appropriate and timely follow-up on the action items, at their respective site(s). Make sure that the most recent versions of the Protocol, Informed Consents, Study Manuals and all the other relevant study-related documents are utilized and implemented at all times for the assigned protocols at their respective site(s). Working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s) Creating and or Reviewing Source Documents for their assigned protocol(s) at their respective site(s) in a timely manner. Responsible for training the site teams and supporting the adequate conduct of study subject visits, and all other relevant protocol required procedures and documenting these in a timely manner. Responsible for enforcing ALCOA-C Standards with all the relevant clinical trial documentation. Responsible for enforcing all Adverse and Serious Adverse Events reporting and any other relevant Safety Information reporting to the appropriate authorities per internal company guidelines, Sponsor, IRB and ICH-GCP Guidelines. Ensuring data quality, subject retention and compliance, and timely and adequate study data reporting on the assigned protocol(s) being conducted at their respective site(s). Working with the cross-functional team(s) and site team(s) to ensure study start readiness on all the aspects and adequate training completed by all the relevant site staff prior to FPFV and continue working with the cross-functional team(s) for the successful execution and completion of the clinical trial. Responsible for clinical trial management from FPFV to study close out with strict adherence to study protocol, adherence to all other relevant study manuals, study documents, ICH-GCP Guidelines, FDA Regulations, and ALCOA-C standards, organizational SOPs and guidance documents. Working closely with the Associate Site Director/Site Director to achieve strategic goals for the site. Assist the Associate Site Director/Site Director with staff training and any other relevant tasks assigned. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Strive to ensure weekly, monthly and quarterly assigned goals are met for their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings. Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff Conduct patient consent discussions and ensure comprehension of medical procedures, risks, benefits, and alternatives Provide clear explanations of study protocols and ensure patients' understanding before obtaining their consent Facilitate effective communication between patients, healthcare providers, and research staff Any other matters as assigned by management. KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required Bachelor's degree preferred Foreign Medical Graduates preferred Experience: Minimum of 5 years experience in Clinical Research Supervisory experience preferred Wide therapeutic range of clinical trials experience preferred Regulatory research experience is a plus Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Goals-driven while continuously maintaining quality. Must be detailed-oriented, proactive, and able to take initiative. Must have strong written and communication skills. Must have excellent customer service skills. Proficient communication and comprehension skills both verbal and written in the English language are required. Proficient Bi-lingual (English/Spanish) communication and comprehension skills both in verbal and written are preferred

About the Job: The Research Coordinator's role is to help the research practice operate more efficiently. They do this by handling the logistics to make research run smoothly so that researchers can focus on what they do best - conduct research. Research Coordinator duties may include project and client management, creating and managing materials for research, participant recruitment and session scheduling, incentive management, tool and data management, etc. What You'll Do: * Coordinate research participant recruitment * o Identify and recruit research participants per researcher specifications * o Coordinate schedules of research participants, researchers, and stakeholders * o Manage incentives * o Manage lists of past and future research participants * Manage software systems used for data collection and analysis * Coordinate with Design Program Managers, Design Leads, and other stakeholders * Work as part of the larger Design Operations team and may be called upon to do operational work for the broader design organization. * If capacity allows, manage projects across the research organization. Including * o Prepare study materials and data collection tools for research sessions * o Schedule planning, research, and report-out sessions for researchers * o Prepare data for analysis * o Create and manage data repositories and handle records retention Skills You Have: * Bachelor's degree, or equivalent * Experience providing operational support to fast-paced research teams. * Experience with research participant recruitment * Demonstrated skills in increasing team efficiency. * Strong communication and organizational skills with attention to the right details to ensure operations run smoothly * An ability to anticipate and proactively solve logistical issues so your team knows they'll never miss a beat when you're coordinating their work Additional Qualifications We'd Love: * 2 years' experience collaborating with live research teams. * Experience working in a highly regulated environment like healthcare or financial services. * Professional association with the Research Ops community. #LI-Hybrid Compensation Range: Pay Range - Start: $60,340.00 Pay Range - End: $112,060.00 Geographic Specific Pay Structure: Structure 110: $66,360.00 USD - $123,240.00 USD Structure 115: $69,370.00 USD - $128,830.00 USD We believe in fairness and transparency. It's why we share the salary range for most of our roles. However, final salaries are based on a number of factors, including the skills and experience of the candidate; the current market; location of the candidate; and other factors uncovered in the hiring process. The standard pay structure is listed but if you're living in California, New York City or other eligible location, geographic specific pay structures, compensation and benefits could be applicable, click here to learn more. Grow your career with a best-in-class company that puts our clients' interests at the center of all we do. Get started now! Northwestern Mutual is an equal opportunity employer who welcomes and encourages diversity in the workforce. We are committed to creating and maintaining an environment in which each employee can contribute creative ideas, seek challenges, assume leadership and continue to focus on meeting and exceeding business and personal objectives.

Cancer Clinical Trials Study Coordinator Required Qualifications (as evidenced by an attached resume): Bachelor's degree (foreign equivalent or higher). In lieu of a Bachelor's degree, a combination of clinical/healthcare, medical type industry setting and/or human research experience totaling four (4) years may be considered. Three (3) years of full-time experience in a clinical/healthcare or medical type industry setting. One (1) year of human research experience. Knowledge of medical terminology. Preferred Qualifications: Experience with coordinating multiple clinical trials. Experience coordinating clinical trials in Oncology. Knowledge of the IRB/regulatory process. IRB training experience. Proficiency with Microsoft Word, Excel and PowerPoint. Brief Description of Duties: At Stony Brook Medicine, a Study Coordinator is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital. Qualified candidates will demonstrate superior patient care and possess outstanding communication skills while adhering to our high standard of excellence. The successful incumbent will have excellent communication and organizational skills. The Study Coordinator will have the ability to work independently with minimal supervision. Duties: Recruit and enroll research subjects and schedule patients. Attend Tumor Board conferences, participate in hospital rounds and staff meetings and review surgical and pathology reports of cancer patients for protocol candidates.Review present protocol patients on therapy to assure toxicity and response to treatment. Follow and maintain records on protocol patients for the duration of the study.Coordinate multiple Oncology Cancer Clinical Trials from inception to closure under the direction of Principal Investigator/Cancer Clinical Trials Administrative Director. Includes screening, eligibility, data collection, adverse event reporting, completion of CRF's and all regulatory requirements per protocol.Plan and coordinate industry-sponsored, cooperative group and investigator initiated clinical research projects including meeting with industry representatives, contract coordination and budget negotiation. Acts as a resource between outside sponsors, industries and SUNY.Draft informed consent forms, assent forms, and other documentation for submission to the IRB.Patient/Staff Education - Educate patients and families as well as oncology staff on the research process and investigational cancer drugs.Other duties as assigned.Special Notes:The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.For this position, we are unable to sponsor candidates for work visas.Resume/CV and cover letter should be included with the online application.Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at ************** or visit OEA.In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here.Visit our WHY WORK HERE page to learn about the total rewards we offer.SUNY Research Foundation: A Great Place to Work.The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting. Job Number: 2504469Official Job Title: Clinical Research Associate IJob Field: Research Professional / TechnicalPrimary Location: US-NY-Stony BrookDepartment/Hiring Area: Cancer CenterSchedule: Full-time Shift :Day Shift Shift Hours: 9:00am- 5:00pm Posting Start Date: Jan 8, 2026Posting End Date: Jan 23, 2026, 4:59:00 AMSalary:$65,000-$80,000Appointment Type: RegularSalary Grade:E99SBU Area:The Research Foundation for The State University of New York at Stony Brook

Cancer Clinical Trials Study Coordinator Required Qualifications (as evidenced by an attached resume): Bachelor's degree (foreign equivalent or higher). In lieu of a Bachelor's degree, a combination of clinical/healthcare, medical type industry setting and/or human research experience totaling four (4) years may be considered. Three (3) years of full-time experience in a clinical/healthcare or medical type industry setting. One (1) year of human research experience. Knowledge of medical terminology. Preferred Qualifications: Experience with coordinating multiple clinical trials. Experience coordinating clinical trials in Oncology. Knowledge of the IRB/regulatory process. IRB training experience. Proficiency with Microsoft Word, Excel and PowerPoint. Brief Description of Duties: At Stony Brook Medicine, a Study Coordinator is a valuable member of our team, who provides administrative support and has the ability to interface with all levels of management throughout the hospital. Qualified candidates will demonstrate superior patient care and possess outstanding communication skills while adhering to our high standard of excellence. The successful incumbent will have excellent communication and organizational skills. The Study Coordinator will have the ability to work independently with minimal supervision. Duties: Recruit and enroll research subjects and schedule patients. Attend Tumor Board conferences, participate in hospital rounds and staff meetings and review surgical and pathology reports of cancer patients for protocol candidates.Review present protocol patients on therapy to assure toxicity and response to treatment. Follow and maintain records on protocol patients for the duration of the study.Coordinate multiple Oncology Cancer Clinical Trials from inception to closure under the direction of Principal Investigator/Cancer Clinical Trials Administrative Director. Includes screening, eligibility, data collection, adverse event reporting, completion of CRF's and all regulatory requirements per protocol.Plan and coordinate industry-sponsored, cooperative group and investigator initiated clinical research projects including meeting with industry representatives, contract coordination and budget negotiation. Acts as a resource between outside sponsors, industries and SUNY.Draft informed consent forms, assent forms, and other documentation for submission to the IRB.Patient/Staff Education - Educate patients and families as well as oncology staff on the research process and investigational cancer drugs.Other duties as assigned.Special Notes:The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.For this position, we are unable to sponsor candidates for work visas.Resume/CV and cover letter should be included with the online application.Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at ************** or visit OEA.In accordance with the Title II Crime Awareness and Security Act a copy of our crime statistics can be viewed here.Visit our WHY WORK HERE page to learn about the total rewards we offer.SUNY Research Foundation: A Great Place to Work.The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU's good faith and reasonable estimate of the range of possible compensation at the time of posting. Job Number: 2504469Official Job Title: Clinical Research Associate IJob Field: Research Professional / TechnicalPrimary Location: US-NY-Stony BrookDepartment/Hiring Area: Cancer CenterSchedule: Full-time Shift :Day Shift Shift Hours: 9:00am- 5:00pm Posting Start Date: Jan 8, 2026Posting End Date: Jan 23, 2026, 4:59:00 AMSalary:$65,000-$80,000Appointment Type: RegularSalary Grade:E99SBU Area:The Research Foundation for The State University of New York at Stony Brook

We are seeking a dedicated Clinical Trial Specialist to join our team, focusing on protocol activation and study accrual. This role involves collaborating with various departments to initiate and activate new clinical trial protocols, ensuring compliance with regulatory requirements, and providing high-quality patient care. The successful candidate will facilitate communication between patients and research teams, manage protocol-specific orders, and ensure adherence to study guidelines. Responsibilities + Collaborate with the Protocol Activation office to initiate and activate new clinical trial protocols, utilizing study-start up task lists. + Prepare and review study tools, including study binders, medication diaries, eligibility checklists, and flow sheets. + Verify Scientific Review Board (SRB), Institutional Review Board (IRB), data collection plans, and finance/contract approvals prior to study activation. + Conduct protocol-related nursing education to facilitate safe, effective care of enrolled patients. + Translate finalized protocol treatment plans, study calendars, and clinical trials billing grids into sample orders. + Coordinate with the clinical research team for timely prescreening of potential subjects and active cancer patients for available clinical trials. + Review patient charts and medical history to confirm protocol eligibility and obtain source documents as needed. + Ensure informed consent processes are followed, and consent is obtained, signed, and documented in medical records. + Provide back-up support for registering consented research patients with study sponsors and input data into the clinical trials database. + Serve as a resource for Clinical Trial Billing Information related to assigned studies. + Act as a link between patients and research team members, addressing and communicating challenges in protocol procedures. + Ensure accurate execution of protocol-specific orders, scheduling, and completion of tests and appointments. + Coordinate protocol-specified procedures and treatments for study patients across disciplines and sites of care. + Manage patient reimbursement while on clinical trials using study-specific methods. + Deliver compassionate oncology nursing care and coordinate with clinical teams as per protocol requirements. + Provide nursing assessments and documentation for protocol-specified visits, ensuring reconciliation of concomitant medications. + Drive collaboration with medical system staff to ensure timely service delivery to patients. + Grade adverse events using protocol-referenced criteria and document toxicities accurately. + Complete Serious/Unexpected Adverse Event forms and ensure accurate completion of follow-up reports. + Assist with monitoring visits, audits, and provide timely responses to sponsor queries. + Maintain research records for screened and enrolled patients, ensuring compliance with regulations and standards. + Participate in training programs, workshops, and disease-specific meetings to stay up-to-date on departmental objectives. + Provide training and orientation to faculty and staff as needed. Essential Skills + Three years of relevant clinical research experience. + Bachelor's Degree required. + Solid knowledge of clinical research processes and oncology. + Comfortable communicating with patients. + Experience in pediatric oncology is preferred. Work Environment Our vision is to be a leader in scientific discovery, patient care, and education in cancer research. We conduct innovative research and cutting-edge patient-centered care to improve cancer outcomes. The clinical operations team consists of 40 FTEs across disease-specific groups such as breast, lung, phase 1, and GI. We operate in Newark and 12 other sites, with a goal of enrolling 5,000 subjects per year in over 300 active trials across all phases, including both adult and pediatric studies. Job Type & Location This is a Contract to Hire position based out of Newark, NJ. Pay and Benefits The pay range for this position is $33.00 - $38.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Newark,NJ. Application Deadline This position is anticipated to close on Jan 27, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

**_About_** **_this_** **_position_** At Henkel, you'll be part of an organization that's shaping the future through innovation, sustainability and collaboration. With our trusted brands like Persil , 'all , Loctite , Snuggle , and Schwarzkopf and our cutting-edge technologies, you'll have countless opportunities to explore new paths and grow. This position is with our Consumer Brands business unit - where we empower our employees to bring the best Laundry & Home Care and Hair products to people around the world. _Henkel's R&D labs are planned to relocate to Trumbull, CT in the latter half of 2027. This position will move with the team. Candidates pursuing this opportunity will be working on-site at our Trumbull R&D center once the relocation is complete._ **Dare to learn new skills, advance in your career and make an impact at Henkel. ** **What you´ll do** Business Context + Henkel CTI team (Consumer Technology & Insights) is looking for its new Clinical Study Coordinator to execute clinical studies for claims support and development of new products. If you are interested in supporting R&D needs with strong clinical data and outstanding innovations, then join our CTI community and be a key contributor at Henkel HCB! Main Purpose of the Job + Steer and coordinate clinical studies to strengthen claims support for the HCB NA R&D Team. Duties and Tasks + With the support of the Clinicals manager: + Executes well designed clinical studies per written protocols. + Interprets study results and recommends next steps, as necessary. + Provides topline results and final reports to study sponsors. + Ensures accurate data is generated during the conduct of the study. + Ensures test instruments are properly maintained and calibrated per standard operating procedures. + Highly customer oriented, interact daily with clinical study subjects. Conduct 1 on 1 interviews, collect medical history information, take vitals and apply beauty care products. **What makes you a good fit** Skills + Knowledge of Good Clinical Practices (GCP), Clinical Coordinator certification preferred + Consistently produces dependable and highly reliable results independently, thorough understanding of clinical test methods and interpretation of results + Ability to work in fluid environment, positive interactions with study subjects, that demands creativity with new product test methods + Good communication skills with product development, clinical subjects, etc, and desire to work in a team environment + Assists in clinical study subject recruitment and maintenance of recruiting database Minimum Qualifications: + Education - Minimum of a B.S. degree and experience in study design and the conduct of clinical trials is preferred. + Experience - 1-3 years of relevant laboratory and industry experience + Skills - Consumer product R&D experience preferred, problem solving skills, communication and analytical skills, quick learner, strong interpersonal skills + Certifications and licenses -Certified Clinical Coordinator would be a plus but not required + Physical Requirements: The physical requirements of this job are consistent with an office job: significant amount of time at a computer station. On rare occasions there is a need to lift up to 20 pounds. **Some benefits of joining Henkel** + **Health Insurance:** affordable plans for medical, dental, vision and wellbeing starting on day 1 + **Work-Life Balance:** Paid time off including sick, vacation, holiday and volunteer time, flexible & hybrid work policies (depending on role), and vacation buy / sell program + **Financial:** 401k matching, employee share plan with voluntary investment and Henkel matching shares, annual performance bonus, service awards and student loan reimbursement + **Family Support:** 12-week gender neutral parental leave (up to 20 weeks for parents giving birth), fertility support, adoption & surrogacy reimbursement, discounted child and elderly care, and scholarships + **Career Growth:** diverse national and international growth opportunities, access to thousands of skills development courses, and tuition reimbursement The salary for this role is $70,000.00 - $80,000.00. This is the range that we in good faith anticipate relying on when setting wages for this position. We may ultimately pay more or less than the posted range and this range. This salary range may also be modified in the future. Henkel does not accept unsolicited resumes from search firms or employment agencies. Unsolicited referrals and resumes are considered Henkel property and therefore, Henkel will not pay a fee for any placement resulting from the receipt of an unsolicited referral. Henkel is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, age, national origin, disability, veteran status, genetic information, and other legally protected categories. **JOB ID:** 25089848 **Job Locations:** United States, CT, Stamford, CT **Contact information for application-related questions:** ***************************** Please do not use this email address for sending your application or CV. To apply, please click on the "Apply for this role" button below. Applications sent via e-mail will not be accepted. **Application Deadline:** As long as the vacancy is listed on our Career Site, we are happy to receive your application **Job-Center:** If you have an application already, you can create or log in to your accounthere (******************************************************************************************************************************************************** to check the status of your application. In case of new account creation, please use your email address that you applied with. Activate external content When clicking the button below external content will be loaded which involves transfer of personal data (e.g. IP address) to external servers. This may involve that cookies are set by the external content provider. Please see Data Protection Statement for further information. **Accept for all YouTube content** Deactivate loading external content from YouTube. How is work at Henkel

Idea Evolver is seeking a forward-thinking AI-Search Coordinator to join our growing team. This is not your typical SEO role-we're looking for someone who understands people and integrates AI into their everyday workflow. As part of our team, you'll explore how audiences discover information across both traditional and emerging AI-driven platforms, translating those insights into strategies that drive content performance and client growth. You'll collaborate closely with leaders in healthcare and other regulated industries to help them adapt to the future of AI-driven digital discovery.What You'll Do Conduct advanced search behavior research using our AI-powered platform, SEMrush, Google Search Console, and other leading tools. Leverage AI to streamline research, surface patterns, and deliver actionable insights faster. Transform search and performance data into clear, compelling stories and recommendations for clients. Support technical SEO best practices to ensure websites meet modern performance, accessibility, and indexability standards. Monitor and interpret performance metrics (via Google Analytics and other platforms), delivering optimization strategies that move the needle. Stay at the forefront of AI-driven search and conversational experiences, helping clients position their content for visibility in these new discovery environments. Deliver client-ready materials-reports, roadmaps, presentations-that drive meaningful business outcomes. What We're Looking For A human who loves what they do and is energized by solving complex problems. A human who wants to contribute to building AI solutions for search and content discovery. 4+ years of experience in SEO, search analytics, or related digital marketing roles. Outstanding communication skills-able to turn complex insights into engaging, client-friendly narratives. Proven ability to collaborate across disciplines in fast-moving, data-driven environments. Experience in healthcare, life sciences, or other regulated industries is a plus. Why Join Idea Evolver Collaborate with a forward-thinking agency at the forefront of AI and search innovation. Partner with high-profile clients in healthcare and consumer industries. Be part of a collaborative, growth-oriented culture where your ideas directly influence outcomes. Enjoy competitive compensation, comprehensive benefits, and opportunities for professional development. Ready to help shape the future of AI-powered search? Apply today to join Idea Evolver's AI-Search & Analytics team and lead the charge into the next era of digital discovery.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes A Difference The Travel Clinical Research Coordinator primary responsibilities are to utilize Good Clinical Practices (GCP) in the process of screening, as well as enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. Due to enhanced experience in Care Access' decentralized clinical research process, the Travel Clinical Coordinator will be able to assume a greater study workload, overall study responsibility, and more detailed, Site, Sponsor and CRO interactions, while conveying a positive image of Care Access to the community, Sponsors, CROs, and study participants and their family members. The Travel Clinical Coordinator is proficient at ICH/GCP, Good Documentation Practices (GDP), and ALCOA-C+. The travel clinical research coordinator role is a mid-level position where the individual has strong working knowledge and experience in the clinical research industry and can perform their duties independently with little day to day guidance from their managers. The Travel Clinical Coordinator will be mentored by their CRC Lead, Site Manager, Senior Manager, and other leaders within clinical operations. How You'll Make An Impact Study Preparation: Ability to understand and follow institutional SOPs Review and assess protocol, study manuals, and the investigator drug brochure (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc. Assist PI, Regulatory, Start-up and the Clinical Trial Manager(s) to ensure that all training and study requirements are met prior to trial conduct Discuss study medication, required procedures, eligibility criteria and impact on clinic flow with your manager, Investigator, and site staff Assist with planning and creation of appropriate recruitment and marketing materials Assist in development of recruitment plan and obtain listing of potential candidates to contact from an internal subject database like StudyTeam, CRIO, etc. Actively work with recruitment team in calling and recruiting subjects for your studies and other site studies Attend Investigator meetings as requested/required and/or coordinate/attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives Assist in the creation or review of protocol specific source documents Determine facility, equipment and outsource vendor requirements and availability Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) and study maintenance Ensure education of Assistant CRCs, research assistants, site staff and/or sub-investigators is completed for required tasks Study Management: Integrate new therapeutic, more complex trial load with existing trial load, delegate tasks as necessary, and prioritize activities with specific regard to protocol timelines and participant safety. Maintain organized file for source documents, patient charts, CRFs, regulatory and study supplies Where appropriate, Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document on accountability log and patient records Collect and evaluate concomitant medications Collect, process, and ship biological specimens as directed by protocol and/or laboratory manual. Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings Ensure trial activities are continuously discussed with covering personnel in preparation of vacation or sick leave Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials Communicate sponsor updates, patient specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of Care Access team in an ongoing fashion Maintain effective relationships with study participants and other Care Access personnel Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management Strong and clear communication skills, both verbally and in writing Accept accountability for actions and function independently Patient Coordination: Prescreen study candidates by telephone and review exclusionary conditions or medications prior to scheduling screening appointment Obtain informed consent per Care Access SOP and document process when revised ICF discussed with patient during course of the trial Administer delegated study questionnaires, where appropriate. Collect and evaluate medical records with the support of medically qualified members of the study team. Complete visit procedures and ensure proper specimen collection, processing and shipment in accordance with protocol Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion Proficient at recognizing adverse events (AEs) and Serious Adverse Events (SAEs) Ensure safety monitoring or symptomatic treatment is initiated as prescribed or as specified in protocol Schedule patients within visit windows, notify personnel as needed for procedures and integrate visits with existing schedules to maximize efficient workflow and patient turnaround Dispense study medication per protocol and/or IVRS systems. Educate patient on proper administration and importance of compliance. Monitor patient progress on study medication Documentation: Record data legibly, in real time on source documents; note additional information that may assist with causality of adverse events, explain protocol deviations, or document patient progress. Correct errors per SOP Accurately record study medication inventory, medication dispensation, and patient compliance. Ensure accurate maintenance of dispensing logs and IVRS confirmation is conducted in a timely fashion. Maintain copies of all prescriptions written for study or non-study medication or procedures in patient chart Accurately transcribe data to CRF or EDC. Resolve data management queries and correct source data as needed Record protocol exemptions and deviations as appropriate with sponsor. Complete Note(s)-to-File for patient chart and regulatory filing if necessary Ensure all sponsor correspondence (e-mail, telephone conversations) are printed and given to appropriate personnel for regulatory filing Maintain copies of patient-specific correspondence in source charts Assist regulatory personnel with completion of continuing/final review reports Perform other duties as assigned. The Expertise Required Excellent working knowledge of clinical trials, medicine and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP), good documentation practices (GDP), and ALCOA-C+ Ability to communicate and work effectively with a diverse team of professionals Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel. Proficiency with technology used to support the clinical trial industry. CTMS systems like CRIO, clinical conductor, Clinical Ink; EDC systems like MediData, Oracle, and Inform; ePRO, eConsent and IWRS/IXRS, etc. Critical thinker and problem solver Friendly, outgoing personality; maintain a positive attitude under pressure High level of self-motivation and energy Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision Certifications/Licenses, Education, and Experience: BS in nursing, pharmacy or other related science or combination of equivalent education preferred in the Arts or Sciences preferred RN or LPN preferred Research Professional Certification- CRCC or exam eligibility preferred A minimum of 3 to 4 years Clinical Research experience A minimum of 2 years prior Clinical Research Coordinator experience, management level preferred. How We Work Together Travel: Extensive travel required. Candidates must be willing to travel 75% of the time nationwide. Duties may require travel for a two-week stretch, followed by one week home. Frequency and length of travel may depend on the length and location of study. The expected salary range for this role is $70,000 - $100,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************